Safety and Efficiency of IRE Plus γδ T Cell Against Locally Advanced Pancreatic Cancer

Fuda Cancer Hospital, Guangzhou

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pancreatic Cancer

Treatments: Biological: IRE plus γδ T cells; Procedure: IRE surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03180437

Gd T cell and Pancreatic Ca

Details and patient eligibility

About

In this study, effects of γδT cells on human Pancreatic Cancer in combination with tumor reducing surgery, for example IRE going to be investigated.

Full description

Pancreatic tumor will be removed using tumor reducing surgery such as IRE. PBMC of the healthy donor will be separated from peripheral blood. After making them potential cancer killer γδ T Cell, they will be infused to the patients as an immunotherapy treatment.

Enrollment: 62 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age: >18 years
2. participants older than 18 years with either LAPC according to the American Joint Committee on Cancer (AJCC) criteria or isolated local recurrence with a maximum tumor diameter of 5 cm were considered eligible after pathologic confirmation
3. will receive IRE, gd Tcells
4. life expectancy: more than 3 months
5. ability to understand the study protocol and a willingness to sign a written informed consent document
6. adequate liver and renal function were required
7. intolerant or refused to chemotherapy or to chemotherapy

Exclusion criteria

1. patients with other kinds of cancer
2. history of coagulation disorders or anemia
3. heart disease and diabetes
4. history of epilepsy, severe coronary disease, a history of level 3 hypertension，myelosuppression, autoimmune disease
5. a performance status score of >2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Group A

Active Comparator group

Description:

In this group, the patients will receive IRE surgery to control the local tumor under CT .

Treatment:

Procedure: IRE surgery

Group B

Experimental group

Description:

In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and IRE surgery

Treatment:

Biological: IRE plus γδ T cells